Company: Varian Medical Systems, Inc.
Date of Enforcement Report 8/31/11
Class ll:
PRODUCT
Eclipse Treatment Planning System; Radiotherapy treatment for patients with malignant and benign diseases. Model No. H48. Recall # Z-2788-2011
REASON
A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated May 20, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
10,356 units
DISTRIBUTION
Nationwide and Internationally
